INTELLISPACE PERINATAL K SMALL ARCH.
Report
- Report Number
- 9610816-2024-00386
- Event Type
- Malfunction
- Date Received
- July 1, 2024
- Date of Event
- June 4, 2024
- Report Date
- September 20, 2024
- Manufacturer
- PHILIPS MEDIZIN SYSTEME BÖBLINGEN GMBH
- Product Code
- HGM
- UDI-DI
- 00884838084490
- PMA / PMN Number
- K100420
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- SZ
- Reporter Occupation
- OTHER HEALTH CARE PROFESSIONAL
- Health Professional
- Yes
Narratives
PHILIPS IS IN THE PROCESS OF OBTAINING ADDITIONAL INFORMATION CONCERNING THIS EVENT AND THE COMPLAINT IS STILL UNDER INVESTIGATION. A FINAL REPORT WILL BE SUBMITTED ONCE THE INVESTIGATION IS COMPLETE. REPORTING INSTITUTION PHONE # (B)(6). REPORTER PHONE # (B)(6). REPORTING ADDRESS STATE (B)(6).
A PHILIPS SOLUTION CENTER LEADER (SCL) SPOKE WITH ONSITE PERSONAL TO EVALUATE THE DEVICE IN QUESTION. THE SCL INDICATED DURING AN EVALUATION OF THE SYSTEM THAT THE PATIENT MEASUREMENT WAS NOT CAUSED BY THE SYSTEM BUT BY A USER MISUNDERSTANDING. THE SCL EXPLAINED TO THE CUSTOMER HOW THE APPLICATION IS INTENDED TO WORK AND THAT THERE IS A DIFFERENCE BETWEEN HOW FETAL MONITOR OPERATES AND HOW SOFTWARE IS WORKING.
THE CUSTOMER REPORTED THAT THE FETAL HEART RATE WAS NOT ABLE TO BE MEASURED. THE DEVICE WAS IN USE ON PATIENT AT TIME OF EVENT, THERE WAS NO ADVERSE EVENT REPORTED.
PHILIPS RECEIVED A COMPLAINT ON THE INTELLISPACE PERINATAL K SMALL ARCH DISPLAYS INACCURATE HEART RATE. THE DEVICE WAS IN USE MONITORING A PATIENT AT THE TIME OF THE EVENT. NO ADVERSE EVENT INVOLVING A PATIENT OR USER WAS REPORTED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 2214200 | INTELLISPACE PERINATAL K SMALL ARCH. | INTELLISPACE PERINATAL K SMALL ARCH. | HGM | PHILIPS MEDIZIN SYSTEME BÖBLINGEN GMBH | 867062 | 00884838084490 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NA | Unknown |